Cardiovascular disease is counted among the most common diseases in Western countries and its occurrence is further increasing. The most important individual risk factor is elevated serum LDL cholesterol level, and therefore, lowering of the blood concentrations of LDL cholesterol is the most effective single measure regarding both prevention and effective treatment of cardiovascular disease.
The most important drugs for reduction of cholesterol levels are the statins, which primarily function by inhibiting the synthesis of cholesterol in the liver. The most common side effects of the statins are gastrointestinal. Other less common side effects include headache, dizziness, rash, and sleep disturbances. In addition, statins may cause both liver damage and muscle disorders, and they have been reported to increase the risk of type II diabetes.
As an alternative to drugs, or in addition to them, also life style changes can reduce the risk of cardiovascular diseases. In particular increasing physical exercise and/or adopting a low-fat or low-cholesterol diet is beneficial. Another nutritional way to reduce the serum LDL cholesterol levels is to use cholesterol lowering ingredients in functional foods that can be consumed as part of a conventional diet. This alternative has been greatly welcomed by consumers.
Foods, such as margarine-type spreads, drinkable and spoonable yoghurts, with added plant sterols and/or plant stanols for effective serum LDL cholesterol lowering are popular in the market place, especially in the European markets. Both in USA and in the EU markets food and dietary supplement products with added plant sterols and/or plant stanols can be marketed with approved coronary heart disease risk reduction health claims due to the serum LDL cholesterol lowering effect, provided that the products fulfil set conditions for use of such health claims. The success of commercial plant sterol and/or plant stanol products is dependent on the possibility to market the products with strong health claims.
In EU the product needs to deliver 1.5-2.4 g equivalents of plant sterols and/or plant stanols in order to bear such a coronary heart disease risk reduction health claim. In USA the latest provision of FDA states that the product needs to deliver at least 0.5 g equivalents of plant sterols and/or plant stanols per Reference Amount Customarily Consumed (RACC) for a total daily intake of 2 g plant sterols and/or plant stanols in order to bear the disease risk reduction health claim. The daily needed 2 g of plant sterols and/or plant stanols can be delivered in 1-4 servings of the food or the dietary supplement.
The current popular plant sterol ester and/or plant stanol ester based foods are products that need continuous refrigeration. However, many consumers would prefer to have their daily dose of plant sterols and/or plant stanols available in a product that can be carried along wherever they go, e.g. as a dietary supplement.
Dietary supplements based on esterified plant sterols and/or plant stanols are currently marketed mainly as so-called soft gelatin capsules. However one problem with this type of product is that the size of the soft gelatin capsule is big, causing problems with the swallowing of it. Such soft gelatin capsules typically deliver about 1 g plant sterol ester and/or plant stanol ester contained in each soft gelatin capsules. Usually the recommended amount of plant sterols and/or plant stanols is 2 g/day, which means that the daily minimum required amount of plant sterol ester and/or plant stanol ester is about 3.4 g. This means that the consumer has to swallow several big soft gelatin capsules per day to obtain the daily recommended amount of plant sterol and/or plant stanol in esterified form. Many consumers have difficulties in swallowing such big capsules. Furthermore the swallowing of such capsules involves simultaneous drinking of water or some other liquid and the capsules are therefore not so convenient to use.
Dietary supplements based on free plant sterols and/or plant stanols are usually compressed tablets. These are usually smaller than the soft gelatin capsules, but liquid is usually required in order to swallow the tablets. However, people with dysphagia may have difficulties in swallowing even smaller sized tablets.
Thus there is a need for a new type of portable plant sterol ester and/or plant stanol ester edible products, such as dietary supplement products. Such products should preferably be easy to consume and be portable with the possibility of being stored at room temperatures and still have long enough shelf life in order to be commercially viable. They should also preferably have good taste. Furthermore such a product should preferably deliver the daily minimum amount of plant sterols and/or plant stanols needed to fulfil the provisions of the cholesterol lowering health claims in various jurisdictions.
It would be advantageous to have a portable edible product, such as a dietary supplement product with a high plant sterol ester and/or plant stanol ester content that can be stored at room temperatures. Furthermore, such an edible product should be easy to consume with limited or no problems in swallowing and it should be possible to consume it without simultaneous consumption of any liquid. Furthermore, such an edible product preferably has low energy content. Good organoleptic properties are desirable. The formulation of the product should preferably also be such that the serum LDL cholesterol lowering effect of the plant sterol and/or plant stanol is good. The current invention satisfies these needs and provides a new type of edible product (such as a dietary supplement product) containing plant sterol ester and/or plant stanol ester.